News Stealth's patience rewarded as FDA approves Barth drug After a long haul, Stealth BioTherapeutics has finally claimed FDA approval for Forzinity, the first treatment for ultra-rare disease Barth syndrome.
News Axe falls on Stealth Bio staff after FDA rejects lead drug Stealth BioTherapeutics' filing for Barth syndrome therapy elamipretide has been turned down by the FDA, but there may be a way forward for the drug.
News Novo faces delay in US review of haemophilia drug The FDA has extended its review of Novo's experimental haemophilia A drug denecimig because of ongoing remediation work at a manufacturing facility.
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